Highlights
- •Intense neoadjuvant therapy doesn't increase the morbidity of radical prostatectomy.
- •Neoadjuvant therapy reduced the rate of positive surgical margins.
- •Neoadjuvant therapy may increase the risk of perioperative thromboembolic events.
Abstract
Introduction
Recent studies about intense neoadjuvant therapy followed by Radical Prostatectomy
(RP) lack standardized criteria regarding surgical complications and comparison to
a group of patients who underwent RP without the use of neoadjuvant therapy. The aim
of this study is to describe and compare the perioperative complication rates.
Materials and Methods
This was a prospective, single-center phase II trial in patients with high-risk prostate
cancer (HRPCa). The control group included HRPCa patients who underwent RP outside
the clinical trial during the same study recruitment period. The interventional group
was randomized (1:1) to receive neoadjuvant androgen deprivation therapy plus abiraterone
with or without apalutamide followed by RP. Complications observed up to 30 days of
surgery were classified based on the Clavien-Dindo classification. Uni- and multivariate
analyses were carried out to assess predictive factors associated with perioperative
complications.
Results
In total, 124 patients with HRPCa were underwent to RP between May 27, 2019 and August
6, 2021, including 61 patients in the intervention group and 63 patients in the control
group. The general and major complications in the intervention group reached 29.6%
and 6.6%, respectively, and 39.7% and 7.9% in the control group, respectively. There
was no significant difference between groups. We observed 4.9% of thromboembolic event
in the neoadjuvant group.
Conclusions
There was no significant increase in morbidity rate in RP after intense neoadjuvant
therapy. The association of intense androgen deprivation neoadjuvant therapy with
RP and extended pelvic lymphadenectomy may increase the risk of a perioperative thromboembolic
events.
Keywords
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Article info
Publication history
Published online: October 21, 2022
Accepted:
October 17,
2022
Received in revised form:
October 15,
2022
Received:
April 24,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
